Testing Medical Devices
Medical devices are often used in life-threatening situations, which means early medical testing is vital to ensuring safety and reliability. CPT℠ provides testing that follows the key regulations and industry standards set forth by the FDA and CDRH (The Center for Devices and Radiological Health).
The program developed by the CDRH highlights safe, reliable medical devices, in addition to radiation-emitting products and newly emerging technologies. The FDA also classifies medical devices based on their risk and efficacy.
There are currently around 1,700 different generic devices, grouped into 16 medical specialties, based on three classes. In order to assess real-world application, testing medical devices is critical based on key risk factors. CPT℠ tests medical devices from every classification. Our team of experts can evaluate everything from low-risk products to products that require the highest level of regulation. This includes operating tables, dental floss, hearing aids, external defibrillators and more.
How We Help Our Clients
At CPT℠, we offer a wide range of programs and services to meet the needs of our clients. When you seek early medical device testing, you can:
- Detect potential vulnerabilities and risk factors. This is especially true regarding the safety of patients and the security of the device itself.
- Gain assistance and guidance as you work through extensive and highly complex processes regarding regulations and documentation.
- Seek proper testing based on class I, II and III devices, increasing the reliability of claims made — while reducing overall risk.
Depending on the medical device being tested, numerous departments may be involved, including:
- In-Vitro Safety — Since the 1970s, our state-of-the-art facility has provided sensitization and dermal irritation testing. Materials and compounds can be studied within medical devices to verify their safety.
- Analytical — At CPT℠, we offer an extensive list of methodologies, such as claims substantiation, comparative evaluations and in-use studies. In relation to medical devices, our Analytical Division will provide support regarding developing and testing.
- Clinical — When it comes to testing medical devices, custom protocols can be created in order to develop and meet specialized testing needs and circumstances. Clinical trials are particularly important when testing medical devices and diabetic products